Indoco Remedies’s Clinical Research Organisation (CRO), AnaCipher, today cleared the US Food and Drug Administration’s (FDA) inspection. The CRO, located in Hyderabad, was inspected by the FDA from 12th to 16th September, 2022. The clinical phase of inspection covered three BA/BE studies submitted by clients to the FDA, and was successfully concluded with zero 483s.
“This is the seventh successive US FDA inspection with zero 483s for AnaCipher CRO. We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients,” said Aditi Kare Panandikar, Managing Director, Indoco Remedies, in the statement.
Further, according to the statement, the CRO also has expertise in bioanalytical work for new chemical entities (phase I-III studies) for pharma companies globally.